Autori: S. Oudard, E. Banu, I. Latorzeff, A. Caty, L. Miglianico, F. Rolland, F. Priou, M. Mourey, P. Beuzeboc, S. Culine
Editorial: Proceedings of Genitourinary Cancers Symposium, 14-16 February, San Francisco, 2008.
Introduction: A prospective, randomized (two-arm), phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in prostate cancer patients (pts) at high risk of systemic recurrence after initial treatment (prostatectomy or radiotherapy). Methods: Eligible prostate cancer pts were required to have a non-metastatic disease with at least one of the following criteria: prostate-specific antigen (PSA) doubling-time (DT) < 6 months, PSA velocity > 0.75 ng/mL/year, Gleason 8-10, positive surgical margins, positive pelvic lymph nodes (N+) and time interval between the local treatment and inclusion < 12 months. The primary endpoint was biochemical (PSA) progression-free survival. The secondary endpoints were safety, metastasis-free survival, overall survival and quality-of-life. Two-sided alpha and power level were 5% and 80%, respectively; 127 pts were necessary in each arm. Randomisation was centrally assigned and stratified according to the initial local treatment (prostatectomy or radiotherapy) and PSA-DT (< 6 or > 6 months). Docetaxel was administered for a total of 6 cycles, 75 mg/m2, day 1, every 3 weeks. The LH-RH agonist (triptorelin) was administered for one year, 10.8 mg every 3 months. A planned safety interim analysis was performed after inclusion of 30 pts. Results: A total of 254 pts were included in 29 centres between June 2003 and September 2007. Median age was 66 years (range 52- 83), 30% of pts had a Gleason score 8-10. A total of 184 pts (72%) were initially operated (49% with positive surgical margins), 28% had an external radiotherapy. Only 3 pts were N+, 59% were pT3 as pathological staging. The median PSA-DT was 6.3 months (range 0.6-42.2). There were no severe toxicities or toxic deaths at the interim analysis. Conclusions: The study is actually closed. Arms were well balanced. Interim safety analysis showed mainly hematological toxicity. More follow-up is needed in order to estimate the impact of chemotherapy associated with hormonal therapy on the outcome of the high-risk prostate cancer patients.
Cuvinte cheie: cancer de prostata, recidiva biochimica, chimioterapie, supravietuire fara semne de progresie // prostate cancer, rising PSA, chemotherapy, progression-free survival